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NCT01605903 · ClinicalTrials.gov registry record · Phase 2
Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy
A Phase 2 study, sponsored by Massachusetts Eye and Ear Infirmary.
- Completed
- Registry status
- Phase 2
- Development phase
- 741
- Enrollment target
NCT01605903 is a Phase 2 study that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 741 participants.
The verdict
NCT01605903, a Phase 2 study, has completed, sponsored by Massachusetts Eye and Ear Infirmary.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 741 participants
- Enrollment target
Study Summary
Tonsillectomy (the surgical removal of the tonsils) is a commonly performed surgery in children. One risk of tonsillectomy is postoperative bleeding, and this can be more dangerous in children because their blood volume is lower than adults. Ibuprofen, a nonsteroidal anti-inflammatory medication (NSAID), is an effective pain medication. Recent guidelines, published by the American Academy of Otolaryngology, advocated use of ibuprofen after tonsillectomy. However, NSAIDs are associated with altered platelet function and a theoretical increased risk of bleeding after surgery. The investigators would like to explore the effect that ibuprofen has on postoperative bleeding, as well as validate previous studies demonstrating it is an effective pain medication after tonsillectomy.
Interventions
- DRUG Acetaminophen
- DRUG Ibuprofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 741 participants |
| Start Date | 2012-05-03 |
| Est. Completion | 2017-02-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01605903
The ClinicalTrials.gov registry entry for NCT01605903 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 741 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts Eye and Ear Infirmary, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Acetaminophen is the first listed.
NCT01605903 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01605903 about?
NCT01605903 is a clinical study titled "Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy". Tonsillectomy (the surgical removal of the tonsils) is a commonly performed surgery in children. One risk of tonsillectomy is postoperative bleeding, and this can be more dangerous in children because their blood volume is lower than adults. Ibuprofen, a nonsteroidal anti-inflammatory medication (NS...
What is the current status of trial NCT01605903?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 741 participants. The study started on 2012-05-03. Estimated completion is 2017-02-15.
What interventions are being tested in trial NCT01605903?
The interventions under investigation include: Acetaminophen (DRUG), Ibuprofen (DRUG).
Who is sponsoring clinical trial NCT01605903?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
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